Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2026-01-09 @ 8:18 AM
Study NCT ID:
NCT03206333
Status:
COMPLETED
Last Update Posted:
2024-02-06
First Post:
2017-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Automated Quantification of Coronary Artery Calcifications on Radiotherapy Planning CTs for Cardiovascular Risk Prediction in Breast Cancer Patients: the BRAGATSTON Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-05', 'studyFirstSubmitDate': '2017-06-28', 'studyFirstSubmitQcDate': '2017-06-30', 'lastUpdatePostDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incident (non-)fatal (cardiovascular) diseases', 'timeFrame': 'Up to 13 years of follow-up, in hazard ratios'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast cancer', 'Cardiovascular diseases', 'Coronary artery calcium', 'Prediction', 'Risk stratification', 'Deep learning technique', 'Software development', 'Computed tomography scan'], 'conditions': ['Breast Cancer', 'Cardiovascular Diseases']}, 'referencesModule': {'references': [{'pmid': '33956083', 'type': 'DERIVED', 'citation': 'Gal R, van Velzen SGM, Hooning MJ, Emaus MJ, van der Leij F, Gregorowitsch ML, Blezer ELA, Gernaat SAM, Lessmann N, Sattler MGA, Leiner T, de Jong PA, Teske AJ, Verloop J, Penninkhof JJ, Vaartjes I, Meijer H, van Tol-Geerdink JJ, Pignol JP, van den Bongard DHJG, Isgum I, Verkooijen HM. Identification of Risk of Cardiovascular Disease by Automatic Quantification of Coronary Artery Calcifications on Radiotherapy Planning CT Scans in Patients With Breast Cancer. JAMA Oncol. 2021 Jul 1;7(7):1024-1032. doi: 10.1001/jamaoncol.2021.1144.'}, {'pmid': '31352417', 'type': 'DERIVED', 'citation': 'Emaus MJ, Isgum I, van Velzen SGM, van den Bongard HJGD, Gernaat SAM, Lessmann N, Sattler MGA, Teske AJ, Penninkhof J, Meijer H, Pignol JP, Verkooijen HM; Bragatston study group. Bragatston study protocol: a multicentre cohort study on automated quantification of cardiovascular calcifications on radiotherapy planning CT scans for cardiovascular risk prediction in patients with breast cancer. BMJ Open. 2019 Jul 27;9(7):e028752. doi: 10.1136/bmjopen-2018-028752.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the BRAGATSTON study is to provide a low cost tool for measuring CAC in breast cancer patients, thereby identifying patients at increased risk of CVD. Breast cancer patients and doctors can act upon this, by adapting the treatment and/or by adopting cardioprotective interventions. Hereby, the burden of CVD in breast cancer survivors can be reduced and better overall survival rates can be achieved.', 'detailedDescription': 'Cardiovascular disease (CVD) is the second most common cause of death in breast cancer patients. Certain adjuvant treatments (e.g. anthracyclines, radiotherapy) increase the risk of CVD, in particular in patients with pre-existing CVD risk factors. Early identification of these patients enables targeted cardioprotective interventions, and switching to less cardiotoxic treatments. The strongest independent CVD risk factor is the presence and amount of coronary artery calcium (CAC). In clinical practice, CAC is quantified on cardiac CTs. Breast cancer patients treated with radiotherapy routinely undergo planning CTs. These inferior quality CTs may give the opportunity to routinely assess CAC.\n\nThe BRAGATSTON study is a multicenter retrospective observational cohort study (UMC Utrecht, Erasmus Medical Center and Radboudumc). The project is divided into three work packages (WP), each WP with a unique aim:\n\nWP 1: To develop/optimize and validate the UMC Utrecht developed automated software to determine the presence and the amount of CAC (CAC score) on radiotherapy planning CT scans of breast cancer patients.\n\nWP 2a: To evaluate the association between CAC score measured automatically on planning CT scans and the risk of incident (non-)fatal cardiovascular events in breast cancer patients.\n\nWP 2b: To evaluate if the association as defined by work package 2a is modified by type of adjuvant treatment.\n\nWP 2c: To evaluate the association between other candidate imaging biomarkers (e.g. calcifications in other structures like the aorta or heart valves, the amount and distribution of body fat, bone characteristics) measured (automatically) on planning CT scans and the risk of incident (non-)fatal (cardiovascular) events in breast cancer patients.\n\nWP 3: To assess the added value of CAC score measured automatically on planning CT scans over classic cardiovascular risk factors and over treatment characteristics to predict (non-)fatal cardiovascular events in breast cancer patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Breast cancer patients treated with radiotherapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Breast cancer patients treated with radiotherapy in UMC Utrecht, Erasmus Medical Center or Radboudumc between 2004-16\n* Planning CT scan available\n* Age: ≥18 years\n* Gender: both genders\n\nExclusion Criteria:\n\n* Not applicable'}, 'identificationModule': {'nctId': 'NCT03206333', 'briefTitle': 'Automated Quantification of Coronary Artery Calcifications on Radiotherapy Planning CTs for Cardiovascular Risk Prediction in Breast Cancer Patients: the BRAGATSTON Study', 'organization': {'class': 'OTHER', 'fullName': 'UMC Utrecht'}, 'officialTitle': 'Automated Quantification of Coronary Artery Calcifications on Radiotherapy Planning CTs for Cardiovascular Risk Prediction in Breast Cancer Patients: the BRAGATSTON Study', 'orgStudyIdInfo': {'id': '16/721 (IRB UMC Utrecht)'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Breast cancer patients treated with radiotherapy'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Radboudumc', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus Medical Center', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'University Medical Center Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}], 'overallOfficials': [{'name': 'Helena M. Verkooijen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imaging Division, University Medical Center Utrecht, Utrecht'}, {'name': 'Ivana Išgum, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Image Sciences Institute, University Medical Center Utrecht, Utrecht'}, {'name': 'Luca Incrocci, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Radiation Oncology, Erasmus Medical Center, Rotterdam'}, {'name': 'Hanneke Meijer, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Radiation Oncology, Radboudumc, Nijmegen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UMC Utrecht', 'class': 'OTHER'}, 'collaborators': [{'name': 'Erasmus Medical Center', 'class': 'OTHER'}, {'name': 'Radboud University Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Helena M Verkooijen', 'investigatorAffiliation': 'UMC Utrecht'}}}}